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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467519
Other study ID # TD517
Secondary ID
Status Completed
Phase Phase 3
First received April 27, 2007
Last updated January 10, 2014
Start date April 2007
Est. completion date December 2009

Study information

Verified date January 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose.

Primary Objective:

- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

Secondary/Observational Objectives:

- To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

- To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.

- To describe the safety profile following vaccine administration.


Recruitment information / eligibility

Status Completed
Enrollment 1045
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria :

- Healthy, as determined by medical history and physical examination.

- Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.

- Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.

- Signed and dated informed assent form from the subject if required by the IRB.

- Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.

- Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).

Exclusion Criteria :

- Participation in another clinical trial in the 4 weeks preceding the trial vaccination.

- Planned participation in another clinical trial during the original trial period.

- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

- Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.

- Chronic illness at a stage that could interfere with trial conduct or completion.

- Blood or blood-derived products received in the past 3 months.

- Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).

- History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).

- Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
0.5 mL, IM
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
0.5 mL, IM

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia. Days 0 to 7 post-vaccination No
Primary Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at = 0.1 IU/mL Level Seroprotection rate at level = 0.1 IU/mL was defined as antibody concentrations = 0.1 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Pre-dose and 30 days post-vaccination No
Primary Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level = 1.0 IU/mL Serothreshold rate at level = 1.0 IU/mL was defined as antibody concentrations = 1.0 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Pre-dose and 30 days post-vaccination No
Primary Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis Booster response was defined as post titer = 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL
Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
30 Days post-vaccination No
Primary Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus Booster response was defined as post titer = 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer = 4 increase and pre-titer = 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer = 2 increase and pre-titer = 2 IU/mL.
Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
30 Days post-vaccination No
Primary Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA). Pre-dose and 30 Days Post-vaccination No
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